- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05753423
Impact of Maternal Mental Health on the Oral Health Status and Oral Health-related Quality of Life of Their Children
March 1, 2023 updated by: Alaa Mohammed Yehia, Ain Shams University
Impact of Maternal Depression, Anxiety, Stress, and Perceived Social Support on the Oral Health Status and Oral Health-related Quality of Life of Their Children
Dental caries is a complex multifactorial disease that is strongly related to and influenced by the children's dietary habits, sugar intake, salivary flow, salivary fluoride level, and preventive behaviors.
Based on the literature, other factors can affect child dental caries including the influence of social factors, such as the family environment.
To avoid suffering from dental caries, preventive oral hygiene practices beginning in childhood are crucial.
However, parents are the primary providers of oral health care for their children and they generally play a pivotal role in the overall health and oral health of both children and adolescents.
Therefore, this study aims to investigate the impact of maternal mental health in the form of depression, anxiety, or stress and their perceived social support on the oral health status and OHRQoL of their children.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
260
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alaa Mohammed Yehia, Ass Lecturer
- Phone Number: 01124488422
- Email: alaa.mohamed.asu@gmail.com
Study Locations
-
-
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Cairo, Egypt, 11566
- Recruiting
- Faculty of Dentistry, Ain Shams University
-
Contact:
- Alaa Mohammed Yehia, Ass Lecturer
- Phone Number: 01124488422
- Email: alaa.mohamed.asu@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Egyptian mothers-children pairs: preschool children of both sexes aged 3-5 years who have a full set of primary dentition and their mothers.
Description
Inclusion Criteria:
- Egyptian mothers.
- Preschool children of both sexes aged (3-5 years who have a full set of primary dentition).
- Healthy children with no long-term medications, and with no physical, learning, or mental disabilities.
Exclusion Criteria:
- Mothers who do not consent to participate in the study (either for themselves or for their children)
- Mothers with any diagnosed mental disorders.
- Pregnant mothers or mothers who delivered within the last year.
- Mothers with any diagnosed physical disabilities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Egyptian mothers-children pairs
Egyptian mothers-children pairs attending the Faculty of Dentistry, Ain Shams University will be recruited.
|
Interview-based questionnaires will be conducted among Egyptian mothers attending Pediatric Dentistry and Dental Public Health outpatient clinic at Faculty of Dentistry, Ain Shams University by the principal investigator.
Clinical examination of the oral health status of their preschool children aged 3-5 years will be conducted by the principal investigator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The presence of maternal mental issue in the form of depression, anxiety, or stress
Time Frame: 1 year
|
The mental health of Egyptian mothers is assessed through the validated Arabic form of the depression anxiety stress scale-21 (DASS-21).
|
1 year
|
The caries experience of their children (aged 3-5 years)
Time Frame: 1 year
|
Dental caries experience is estimated by calculating the three components (decayed, missed, and filled) of the dmft index for primary teeth according to World Health Organization (WHO).
|
1 year
|
The oral hygiene status of their children (aged 3-5 years)
Time Frame: 1 year
|
Oral hygiene is assessed by the debris component of the modified form of Oral Hygiene Index-Simplified (OHI-S) that can be used for deciduous teeth.
|
1 year
|
Oral health-related quality of life of their children
Time Frame: 1 year
|
A validated Arabic version of the Early Childhood Oral Health Impact Scale (ECOHIS) is used to examine mothers' perceptions of their preschool children's oral health-related quality of life (OHRQoL).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The perceived social support of Egyptian mothers
Time Frame: 1 year
|
The perceived social support of Egyptian mothers is assessed by the multidimensional scale of perceived social support (Arabic- MSPSS).
|
1 year
|
The oral health-related behaviors of their children
Time Frame: 1 year
|
Egyptian mothers are asked five questions about their children's snacking habit, frequency of tooth brushing, brushing with or without adult assistance, and dental visit utilization and pattern.
These questions were adopted from previous similar studies in English and then were translated into Arabic.
|
1 year
|
The perception of Egyptian mothers about the dental health status of their children
Time Frame: 1 year
|
Participants are asked to rate the dental health status of their children on a 5-point scale from 'very good' to 'very poor'.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- GBD 2017 Oral Disorders Collaborators; Bernabe E, Marcenes W, Hernandez CR, Bailey J, Abreu LG, Alipour V, Amini S, Arabloo J, Arefi Z, Arora A, Ayanore MA, Barnighausen TW, Bijani A, Cho DY, Chu DT, Crowe CS, Demoz GT, Demsie DG, Dibaji Forooshani ZS, Du M, El Tantawi M, Fischer F, Folayan MO, Futran ND, Geramo YCD, Haj-Mirzaian A, Hariyani N, Hasanzadeh A, Hassanipour S, Hay SI, Hole MK, Hostiuc S, Ilic MD, James SL, Kalhor R, Kemmer L, Keramati M, Khader YS, Kisa S, Kisa A, Koyanagi A, Lalloo R, Le Nguyen Q, London SD, Manohar ND, Massenburg BB, Mathur MR, Meles HG, Mestrovic T, Mohammadian-Hafshejani A, Mohammadpourhodki R, Mokdad AH, Morrison SD, Nazari J, Nguyen TH, Nguyen CT, Nixon MR, Olagunju TO, Pakshir K, Pathak M, Rabiee N, Rafiei A, Ramezanzadeh K, Rios-Blancas MJ, Roro EM, Sabour S, Samy AM, Sawhney M, Schwendicke F, Shaahmadi F, Shaikh MA, Stein C, Tovani-Palone MR, Tran BX, Unnikrishnan B, Vu GT, Vukovic A, Warouw TSS, Zaidi Z, Zhang ZJ, Kassebaum NJ. Global, Regional, and National Levels and Trends in Burden of Oral Conditions from 1990 to 2017: A Systematic Analysis for the Global Burden of Disease 2017 Study. J Dent Res. 2020 Apr;99(4):362-373. doi: 10.1177/0022034520908533. Epub 2020 Mar 2.
- Lorber MF, Maisson DJ, Slep AM, Heyman RE, Wolff MS. Mechanisms Linking Interparental Aggression to Child Dental Caries. Caries Res. 2017;51(2):149-159. doi: 10.1159/000453672. Epub 2017 Jan 28.
- Alshammari FS, Alshammari RA, Alshammari MH, Alshammari MF, Alibrahim AK, Al Sineedi FA, Alkurdi KA, Alshammari AF. Parental Awareness and Knowledge toward their Children's Oral Health in the City of Dammam, Saudi Arabia. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):100-103. doi: 10.5005/jp-journals-10005-1894.
- Abanto J, Carvalho TS, Mendes FM, Wanderley MT, Bonecker M, Raggio DP. Impact of oral diseases and disorders on oral health-related quality of life of preschool children. Community Dent Oral Epidemiol. 2011 Apr;39(2):105-14. doi: 10.1111/j.1600-0528.2010.00580.x. Epub 2010 Oct 5.
- Alkan A, Cakmak O, Yilmaz S, Cebi T, Gurgan C. Relationship Between Psychological Factors and Oral Health Status and Behaviours. Oral Health Prev Dent. 2015;13(4):331-9. doi: 10.3290/j.ohpd.a32679.
- Costa FDS, Azevedo MS, Ardenghi TM, Pinheiro RT, Demarco FF, Goettems ML. Do maternal depression and anxiety influence children's oral health-related quality of life? Community Dent Oral Epidemiol. 2017 Oct;45(5):398-406. doi: 10.1111/cdoe.12303. Epub 2017 Apr 17.
- Gavic L, Tadin A, Mihanovic I, Gorseta K, Cigic L. The role of parental anxiety, depression, and psychological stress level on the development of early-childhood caries in children. Int J Paediatr Dent. 2018 Nov;28(6):616-623. doi: 10.1111/ipd.12419. Epub 2018 Aug 24.
- Burgette JM, Polk DE, Shah N, Malik A, Crout RJ, Mcneil DW, Foxman B, Weyant RJ, Marazita ML. Mother's Perceived Social Support and Children's Dental Caries in Northern Appalachia. Pediatr Dent. 2019 May 15;41(3):200-205.
- Mohammad S, Almakran IW, Al-Montashri AS, Mursi AM, Alharbi SM, Pasha TS, Khalid I. Depression, anxiety and stress and their associated social determinants in the Saudi college students. Health Psychol Res. 2020 Dec 30;8(3):9263. doi: 10.4081/hpr.2020.9263. eCollection 2020 Dec 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2022
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
March 1, 2023
First Posted (Actual)
March 3, 2023
Study Record Updates
Last Update Posted (Actual)
March 3, 2023
Last Update Submitted That Met QC Criteria
March 1, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DPH 22-1D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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